Nctid:
NCT06229171
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006973", "term"=>"Hypertension"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M10024", "name"=>"Hypertension", "asFound"=>"Hypertension", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>206}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Adherence (plasma essay - 3m)", "timeFrame"=>"after 3 months of randomized intervention", "description"=>"Percentage of adherent patients based on plasma essay at follow-up visit"}], "secondaryOutcomes"=>[{"measure"=>"adherence (pill count - 3m)", "timeFrame"=>"after 3 months of randomized intervention", "description"=>"percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit"}, {"measure"=>"adherence (voice assistant - 3m)", "timeFrame"=>"after 3 months of randomized intervention", "description"=>"percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit"}, {"measure"=>"adherence (questionnaire - 3m)", "timeFrame"=>"after 3 months of randomized intervention", "description"=>"percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit"}, {"measure"=>"Adherence (plasma essay - 5m)", "timeFrame"=>"after 5 months", "description"=>"percentage of adherent patients based on plasma essay at final visit"}, {"measure"=>"adherence (pill count - 5m)", "timeFrame"=>"after 5 months", "description"=>"percentage of adherent patients based on pill count adherence (AdhVA) at final visit"}, {"measure"=>"adherence (voice assistant - 5m)", "timeFrame"=>"after 5 months", "description"=>"percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit"}, {"measure"=>"adherence (questionnaire - 5m)", "timeFrame"=>"after 5 months", "description"=>"percentage of adherent patients based on MARS-5I at final visit"}, {"measure"=>"24h Systolic Blood Pressure (3m)", "timeFrame"=>"after 3 months of randomized intervention", "description"=>"24-hour systolic blood pressure (ABPM) at follow-up visit"}, {"measure"=>"24h Systolic Blood Pressure (5m)", "timeFrame"=>"after 5 months", "description"=>"24-hour systolic blood pressure (ABPM) at final visit"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Personalized Medicine"], "conditions"=>["Hypertension", "Treatment Adherence and Compliance", "Digital Health"]}, "descriptionModule"=>{"briefSummary"=>"Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems.\n\nThis interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult (\\>18 years old) patients\n* History of essential hypertension\n* Treatment with at least one antihypertensive drug for which dedicated plasma essay is available\n* wireless internet connection available at patients' home\n* stable clinical conditions\n* written informed consent\n\nExclusion Criteria:\n\n* insufficient technological literacy to manage vocal assistant\n* dementia or significant psychiatric disorders\n* conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language)\n* pregnancy or breastfeeding\n* active cancer (except basal cell skin carcinoma)\n* upper limb amputation"}, "identificationModule"=>{"nctId"=>"NCT06229171", "acronym"=>"InTakeCare", "briefTitle"=>"InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention", "organization"=>{"class"=>"OTHER", "fullName"=>"Istituto Auxologico Italiano"}, "officialTitle"=>"InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention", "orgStudyIdInfo"=>{"id"=>"09M201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"usual practice"}, {"type"=>"EXPERIMENTAL", "label"=>"vocal assistant", "interventionNames"=>["Other: adherence support system based on a vocal assistant"]}], "interventions"=>[{"name"=>"adherence support system based on a vocal assistant", "type"=>"OTHER", "description"=>"Participants in the intervention group will receive a vocal assistant device and the instructions/support for the activation of the system at their homes. The device will remind the participant, at the times defined during set-up, which therapy should be taken and with what dosage. The participant will have 30 minutes from the first reminder to confirm vocally that the therapy has been taken, which will otherwise be considered as not having been taken.\n\nParticipants in the control group will receive verbal advice from the physician about the need to follow the treatment recommendations and simple indications on possible solutions to maintain adherence, as by the usual practice of the Centre.", "armGroupLabels"=>["vocal assistant"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Grzegorz Bilo, MD, PhD", "role"=>"CONTACT", "email"=>"g.bilo@auxologico.it", "phone"=>"+390261911", "phoneExt"=>"2903"}, {"name"=>"Lucia Zanotti, Bsc, PhD", "role"=>"CONTACT", "email"=>"l.zanotti@auxologico.it", "phone"=>"+390261911", "phoneExt"=>"2714"}], "overallOfficials"=>[{"name"=>"Grzegorz Bilo, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Istituto Auxologico Italiano"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Istituto Auxologico Italiano", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Istituti Clinici Scientifici Maugeri SpA", "class"=>"OTHER"}, {"name"=>"Politecnico di Milano", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
